Legis Daily

BLOCKING Act of 2019

USA116th CongressHR-938| House 
| Updated: 5/2/2019
Kurt Schrader

Kurt Schrader

Democratic Representative

Oregon

Cosponsors (16)
Mark Meadows (Republican)Joseph P. Kennedy (Democratic)Ben McAdams (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)Bobby L. Rush (Democratic)Greg Walden (Republican)Debbie Dingell (Democratic)Angie Craig (Democratic)Earl L. "Buddy" Carter (Republican)Doris O. Matsui (Democratic)Anna G. Eshoo (Democratic)Debbie Mucarsel-Powell (Democratic)Janice D. Schakowsky (Democratic)Yvette D. Clarke (Democratic)Frank Pallone (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.

Bill Text Versions

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2 versions available

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Timeline
Jan 31, 2019
Introduced in House
Jan 31, 2019
Referred to the House Committee on Energy and Commerce.
Feb 2, 2019
Referred to the Subcommittee on Health.
Mar 27, 2019
Subcommittee Consideration and Mark-up Session Held.
Mar 27, 2019
Forwarded by Subcommittee to Full Committee by Voice Vote .
Apr 3, 2019
Committee Consideration and Mark-up Session Held.
Apr 3, 2019
Ordered to be Reported by Voice Vote.
May 2, 2019
Placed on the Union Calendar, Calendar No. 24.
May 2, 2019
Reported by the Committee on Energy and Commerce. H. Rept. 116-46.
  • January 31, 2019
    Introduced in House


  • January 31, 2019
    Referred to the House Committee on Energy and Commerce.


  • February 2, 2019
    Referred to the Subcommittee on Health.


  • March 27, 2019
    Subcommittee Consideration and Mark-up Session Held.


  • March 27, 2019
    Forwarded by Subcommittee to Full Committee by Voice Vote .


  • April 3, 2019
    Committee Consideration and Mark-up Session Held.


  • April 3, 2019
    Ordered to be Reported by Voice Vote.


  • May 2, 2019
    Placed on the Union Calendar, Calendar No. 24.


  • May 2, 2019
    Reported by the Committee on Energy and Commerce. H. Rept. 116-46.

Health

Related Bills

  • HR 116-2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • HR 116-987: Strengthening Health Care and Lowering Prescription Drug Costs Act
Competition and antitrustDrug safety, medical device, and laboratory regulationHealth care costs and insuranceHealth care coverage and accessLicensing and registrationsMarketing and advertisingPrescription drugs

BLOCKING Act of 2019

USA116th CongressHR-938| House 
| Updated: 5/2/2019
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 31, 2019
Introduced in House
Jan 31, 2019
Referred to the House Committee on Energy and Commerce.
Feb 2, 2019
Referred to the Subcommittee on Health.
Mar 27, 2019
Subcommittee Consideration and Mark-up Session Held.
Mar 27, 2019
Forwarded by Subcommittee to Full Committee by Voice Vote .
Apr 3, 2019
Committee Consideration and Mark-up Session Held.
Apr 3, 2019
Ordered to be Reported by Voice Vote.
May 2, 2019
Placed on the Union Calendar, Calendar No. 24.
May 2, 2019
Reported by the Committee on Energy and Commerce. H. Rept. 116-46.
  • January 31, 2019
    Introduced in House


  • January 31, 2019
    Referred to the House Committee on Energy and Commerce.


  • February 2, 2019
    Referred to the Subcommittee on Health.


  • March 27, 2019
    Subcommittee Consideration and Mark-up Session Held.


  • March 27, 2019
    Forwarded by Subcommittee to Full Committee by Voice Vote .


  • April 3, 2019
    Committee Consideration and Mark-up Session Held.


  • April 3, 2019
    Ordered to be Reported by Voice Vote.


  • May 2, 2019
    Placed on the Union Calendar, Calendar No. 24.


  • May 2, 2019
    Reported by the Committee on Energy and Commerce. H. Rept. 116-46.
Kurt Schrader

Kurt Schrader

Democratic Representative

Oregon

Cosponsors (16)
Mark Meadows (Republican)Joseph P. Kennedy (Democratic)Ben McAdams (Democratic)Raul Ruiz (Democratic)Jefferson Van Drew (Republican)Bobby L. Rush (Democratic)Greg Walden (Republican)Debbie Dingell (Democratic)Angie Craig (Democratic)Earl L. "Buddy" Carter (Republican)Doris O. Matsui (Democratic)Anna G. Eshoo (Democratic)Debbie Mucarsel-Powell (Democratic)Janice D. Schakowsky (Democratic)Yvette D. Clarke (Democratic)Frank Pallone (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 116-2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • HR 116-987: Strengthening Health Care and Lowering Prescription Drug Costs Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Competition and antitrustDrug safety, medical device, and laboratory regulationHealth care costs and insuranceHealth care coverage and accessLicensing and registrationsMarketing and advertisingPrescription drugs